Sanofi announced that the results of a pre-determined analysis of data pooled from the Pivotal Phase III Melody Trial and the Nirsevimab Phase IIb Trial showed an efficacy of 79.5% (95 CI: 65.9 to 87.7) (relative risk reduction compared to placebo); <0.0001) Against lower respiratory tract infections that require medical management, such as bronchiolitis or pneumonia, RSV1 in infants born prematurely or late in the first season of RSV transmission.
According to the results of post-HAK analysis of data collected from the trial, the concentration of neutral antibodies against RSV was 50 times higher than baseline, 51 days after dosing in blood samples taken from children receiving the dose of nirsivimab. The concentration of anti-RSV-neutral antibodies remains 19-times higher than in placebo-given infants, without knowing RSV infection for 361 days, suggesting that protection is maintained even after 151-dose 2.
The safety profiles of the Nirsevimab and placebo groups were similar to those reported in previous trials 3-6. These results complement the growing body of evidence suggesting that Nirsevimab may protect all babies for the duration of their first RSV season, a single dose of 1-7.
Dr. Eric Simoes, Clinical Professor, Pediatric Infectious Diseases, University of Colorado Denver School of Medicine
“RSV remains the most common cause of lower respiratory infections in children and causes seasonal epidemics worldwide each year. These new analyzes show that Nirsevimab has the ability to protect all children for the duration of the RSV transmission season in a single dose, which prevents infections caused by the virus. It could be a game-changer.
Jean-François Toussaint, Global Head, Vaccines Research and Development, Sanofi. We are proud of the progress we have made in creating a potential solution for all children who meet long-term unnecessary needs. A
Mane Pangalos, Executive Vice President, Biopharmaceuticals R&D, AstraZeneca: “Every year, RSV causes a seasonal outbreak of lower respiratory tract infections in children. These reviews complement the main body of evidence of nirsevimab and illustrate the potential of being the first possible single-dose resistant RSV immunization agent, thus addressing a clear need for prevention of infection caused by this virus. A
The data will be presented at the 40th Annual Congress of the European Society for Pediatric Infectious Diseases (ESPID) to be held in Athens, Greece on May 9-13. Nirsevimab is made by Sanofi and AstraZeneca.
1. Simões, E, et al. RSV in premature and premature infants Poly efficacy of Nirsevimab against lower respiratory tract infections. ESPID 2022 Congress; 2022 May 9-13. Hybrid Congress. Abstract [#XX]
2. Wilkins, D, et al. Nirsevimab for prevention of respiratory syncytial virus infection: neutralizing antibody levels following a single dose. ESPID 2022 Congress; 2022 May 9-13. Hybrid Congress. Abstract [#XX]
3. Hamit LL, MD and others. Nirsevimab for RSV prevention in healthy late-preterm and term infants. N English J Med. 2022; 386 (9): 837-846. doi: 10.1056 / NEJMoa2110275.
4. Griffin P, MD and others. (2020). Single-dose Nirsevimab for RSV prevention in preterm infants. NEJM 2020; 383: 415-425. DOI: 10.1056 / NEJMoa1913556.
5. Clinicaltrials.gov. A study to evaluate the safety and efficacy of MEDI8897 for RSV LRTI prevention medically present in healthy late preterm and term infants (melody). https://clinicaltrials.gov/ct2/show/NCT03979313. Accessed April 2022.
6. Clinicaltrials.gov. A study to evaluate the safety and efficacy of MEDI8897 for the prevention of medically attended RSV LRTI in healthy preterm infants. (MEDI8897 Ph2b). https://clinicaltrials.gov/ct2/show/results/NCT02878330. Accessed April 2022.
7. Clinicaltrials.gov. A study to evaluate the safety of MEDI8897 for the prevention of medically attended respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in high-risk children. https://clinicaltrials.gov/ct2/show/NCT03959488. Accessed April 2022.
Source and Visual: Sanofi